Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

Recruiting now · Not applicable

Conditions studied: Intracranial Atherosclerotic Stenosis

In brief

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

Key facts

Study ID

NCT06857058

Run by

Sino Medical Sciences Technology Inc.

People needed

300

Starts

2024-03-08

Expected to finish

2026-06-08

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females between 18 and 80 years of age
• Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
• Intracranial artery stenosis ( ≥70%) conformed by DSA
• Those who voluntarily participate in the study and sign informed consent form

You may not qualify if…

• Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
• Subjects of acute hemorrhagic stroke within 3 months;
• The baseline mRS of disabling stroke is more than 3;
• The target vessel is severely calcified and closely related to stenosis;
• Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
• It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
• The presence of a >50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis >50% should be excluded;
• There are intracranial tumors, or intracranial arteriovenous malformations;
• Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
• Pregnant and lactating women
• Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
• Inapplicable for this study at the investigators' viewpoints.

Where it is running

• The first affiliated hospital of zhengzhou university — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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